HHS FDA Classifies Tinnitus Relief Device Into Class II Category
June 11, 2026
June 11, 2026
WASHINGTON, June 11 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has classified a combined acoustic and electrical external stimulation device for the relief of tinnitus into Class II by establishing special controls that the agency said will provide reasonable assurance of safety and effectiveness while helping expand patient access to treatment options.
Neuromod Devices Ltd. submitted its De Novo request to FDA on August 18, 2021, seekin . . .
Neuromod Devices Ltd. submitted its De Novo request to FDA on August 18, 2021, seekin . . .